A Single and Multiple Ascending Dose Escalation and Food Effect Study of QX-4533 in Healthy Participants

NCT07678463 | Recruiting Phase 1 DMC

• 1 other identifier: QX4533-001
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the safety and tolerability of QX-4533 following oral administration of single and multiple ascending doses in healthy participants.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Treatment-emergent Adverse Events (TEAEs)

  From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])

• Number of Participants with Clinically Significant Change from Baseline in Clinical Laboratory Parameters

  From enrollment through the safety follow-up visit (up to Day 9 [Part 1] and Day 23 [Part 2])

Secondary Outcomes (8)

• Maximum Observed Plasma Concentration (Cmax)

  Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)

• Time of the Maximum Measured Concentration (Tmax)

  Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)

• Area Under the Concentration-Time Curve from Time Zero to the Last Quantifiable concentration-time point (AUClast)

  Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)

• Area Under the Concentration-Time Curve from Time Zero Extrapolated to Infinity (AUCinf)

  Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)

• Apparent Volume of Distribution at Steady State (Vz/F)

  Day 1 (Part 1); Day 1, Day 7, and Day 14 (Part 2)

Study Arms (4)

Part 1: Single Ascending Dose (SAD)

EXPERIMENTAL

Participants will receive a single oral dose of QX-4533 or placebo on Day 1, under fasting conditions.

Drug: QX-4533; Drug: Placebo

Part 2: Multiple Ascending Dose (MAD)

EXPERIMENTAL

Participants will receive multiple oral doses of QX-4533 or placebo, once daily for 14 days under fasting conditions.

Drug: QX-4533; Drug: Placebo

Part 3: Food Effect - Sequence 1: AB

EXPERIMENTAL

Participants will receive single oral dose of QX-4533 on Day 1 of Period 1 under fasted condition (A) followed by single oral dose of QX-4533 on Day 1 of Period 2 under fed (high fat meal) condition (B).

Drug: QX-4533

Part 3: Food Effect - Sequence 2: BA

EXPERIMENTAL

Participants will receive a single oral dose of QX-4533 on Day 1 of Period 1 under fed (high fat meal) condition (B) followed by single oral dose of QX-4533 on Day 1 of Period 2 under fasted condition (A).

Drug: QX-4533

Interventions

QX-4533 DRUG

QX-4533 tablets

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD); Part 3: Food Effect - Sequence 1: AB; Part 3: Food Effect - Sequence 2: BA

Placebo DRUG

QX-4533 matched-placebo tablets

Part 1: Single Ascending Dose (SAD); Part 2: Multiple Ascending Dose (MAD)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female between 18 and 55 years of age (inclusive) at screening.
• Understands the study procedures and is capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• Willing and able to comply with this protocol and be available for the entire duration of the study.
• In good general health, determined by no clinically significant findings in the opinion of the Investigator from medical history, physical examination, 12-lead electrocardiogram (ECG), clinical laboratory findings, and vital signs at screening and Day -1.
• Has body mass index of 18 to 32 kilograms per meter square (kg/m\^2) inclusive.

You may not qualify if:

• History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease according to the Investigator.
• History of any Gastrointestinal (GI) procedures (e.g., bariatric surgery) that could impair gastrointestinal absorption.
• History of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the participant.
• Clinically significant abnormalities on pre-study clinical examination or laboratory safety tests. Laboratory safety assessments (e.g., serum chemistry, hematology, coagulation) will be performed at screening and on Day -1 (if screening is prior to Day -1) to confirm eligibility.
• Treatment with a live (attenuated) vaccine within 8 weeks before the screening visit.
• Positive hepatitis B surface antigen, human immunodeficiency virus antibody, or hepatitis C antibody at the screening visit.
• Use of any prescription within 14 days prior to study treatment administration or use of any over-the-counter medications including food supplements and herbal medications (e.g., St. John's wort), except for contraceptive medications and as needed (pro re nata) paracetamol (not exceeding 2 g/day) within 7 days prior to study treatment administration.
• Participant has participated in another clinical study within the last 4 weeks or within 5 half-lives of the prior study drug, whichever is longer.
• Participants that currently use (including "recreational use") any illicit drugs or have a history of drug abuse in the last 2 years.

Sponsors & Collaborators

• QuantX Biosciences, Inc.: lead

Study Sites (1)

Nucleus Network Brisbane (Q-pharm)

Brisbane, Queensland, Australia

RECRUITING

Study Officials

• Gregory Bell, MD

  Leader of Clinical Development Department

  STUDY CHAIR

Central Study Contacts

Shu Wang, MD

CONTACT

+86 18036618586; shu.wang@quantxbio.com

Yiting Chi, MD

CONTACT

+86 13482779422; Yiting.Chi@quantxbio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: FE study will be open label.
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 3 FE is Cross over study model.

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 1, 2026
• Study Start: July 10, 2026
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)